Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis (CUCART)

Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From Cucumber on the Articular Pain of Diagnosed Patients of Arthrosis

Randomized, controlled, double-blind clinical trial of two parallel branches to analyze the efficacy of a supplement extracted from the cucumber on the joint pain of patients diagnosed with osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: nutraceutical

Detailed Description

The subjects that meet the selection criteria will make a total of two visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 40 years.
• Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
• Subjects must have persistent knee pain associated with osteoarthritis with a baseline score of at least 30 mm on the VAS pain assessment.
• Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.

Exclusion Criteria:

• Serious or terminal illnesses.
• Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
• Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
• Subjects with a body mass index above 32.
• Pregnant or lactating women.
• Inability to understand informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (cucumber); Consumption for 90 days of cucumber extract (20mg/day) Two capsules a day orally for 90 days.	Dietary supplement: nutraceutical; Subjects will consume two capsules for eight weeks
Placebo Comparator: control group Placebo (sucrose); Two capsules a day orally for 90 days.	Dietary supplement: nutraceutical; Subjects will consume two capsules for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain from baseline at 8 weeks	Visual analog scale from 0 to 10. The higher the value, the more pain.	The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in concomitant analgesic medication	The change in the need for the use of analgesic medications will be evaluated.	Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Quality of life test: WOMAC test	The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain: nothing, little, enough, a lot, and a lot, when performing activities in daily life.	it will be measured twice, once at baseline or at the end of the study after 8 weeks of use
Functional test	The balance and mobility of the subjects will be measured with the Timed Up and Go Test	Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Muscle function	Isokinetic dynamometry.	Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Inflammatory state IL-b	It is a blood test that measures cartilage degradation	Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Cartilage metabolism	It is a blood test that measures cartilage degradation	Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)	Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: UCAMCFE-00017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No